Overview

A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

Status:
Terminated

Trial end date:
2004-10-05

Target enrollment:
0

Participant gender:
All

Summary

The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Rofecoxib
Valdecoxib

Criteria

Inclusion Criteria:

- Patients had sustained, no more than 48 hours prior to the first dose of study
medication, a first- or second-degree ankle sprain of the lateral ligament,
specifically: anterior talofibular ligament and/or posterior talofibular ligament
and/or calcaneofibular ligament

- At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual
Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight
bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's
Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity

- Tthe investigator opinion was that each patient required, and was eligible for,
therapy with an anti-inflammatory agent and/or analgesics to control symptoms

Exclusion Criteria:

None reported